Moderna said it’s requesting a meeting with the U.S. Food and Drug Administration after receiving a “refusal-to-file” letter, which means the FDA isn’t going to review the company’s advanced-stage ...
By Nate Raymond BOSTON, Feb 12 (Reuters) - Health and Human Services Secretary Robert F. Kennedy Jr.'s sweeping efforts to ...
Percentage of Americans who see flu and measles vaccines as safe is declining - A new survey’s findings come amid a historic ...
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it ...
The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA ...
FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.
The F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
In December, the Centers for Medicare and Medicaid Services announced an end to state vaccine reporting requirements, ...
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Safety perceptions of major vaccines show significant drop over the past three years
In a winter marked by flu outbreaks, the persistence of Covid-19, and surges of measles cases across the United States, an ...
You can’t blame this one on the stork. After a brief baby bump early in the COVID-19 pandemic, birth rates in the US and ...
Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...
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